Senior Medical Information Specialist
2 weeks ago
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Job Title: Senior Medical Information Specialist
Location: Dallas, TX - Hybrid OR Boston, MA - Hybrid
The Senior Medical Information Specialist position is integral to the organization to maintain compliance in accordance with regulations and laws established by federal authorities. This position is the point of contact and lead for training and planning and execution for activity related to Medical Information in a specific product or disease area. This role will engage with healthcare professionals and processes Medical Information (MI) requests received from external customers for all Business Units. This role also acts as a lead for the Medical Information team responsible for department processes and other general activity.
Essential Functions
Liaise with BU Medical team, other departments, affiliates, and third parties (e.g., vendors and agencies) to anticipate impending product launches, product labeling updates, emerging literature, industry trends, and clinical study data. Acts as point of contact for these partners that represents department in meetings.Create and maintain standard (e.g., MI Letters and Frequently Asked Questions, etc.) and custom responses to communicate disease state, product information, and other general information to internal and external customers.Engage with healthcare professionals (HCPs) including relaying responses to HCPs and participating in external engagement activities such as scientific congresses.Develop and deliver training to applicable MI vendors and partners (e.g., Call Center vendors, Sales, Medical, Quality, Pharmacovigilance etc.) on MI content (i.e., product or disease state training, processes, templates, etc.).Lead and provide work direction and training to team members, business partners, and third parties (e.g., product, disease state, department processes, etc.).Ensure a state of inspection readiness adhering to and maintaining department policies and processes. Monitor MI Call Center cases in accordance with MI compliance (i.e., applicable GLLP Standard Operating Procedures and Work Instructions and FDA, GCP, PhRMA, OIG, ACCME, and other relevant guidelines and regulations). C ompile MI data analysis and provide timely feedback to remediate findings.
Minimum Education, Knowledge, Skills, and Abilities
Bachelor's degree required, advanced degree in related field preferred. L icensed health care professional (PhD, PharmD, RN, NP, PA) preferre d.Minimum of five (5) years medical or clinical related experience in medical affairs, medical writing, or clinical role in pharmaceutical industry or medical communications agency required. Experience with Medical Information systems preferred (e.g., IRMS, Lifesphere Medical Affairs, Veeva MedComms, etc.) Knowledge of ICH, GCP, FDA, OIG, HIPAA and other applicable regulations. Experience managing major projects. Familiarity with clinical trial design and statistics and their application to the interpretation and presentation of clinical data. Experience with Corporate setting and the ability to think strategically and to model and guide compliant behavior. Successful track record demonstrating strong analytical and organization skills demonstrating the ability to drive process improvement and quality assurance. Ability to organize, prioritize, and maintain high quality work output in a fast-paced dynamic environment while working on multiple projects . Strong writing skills, with a demonstrated record of scientific/medical writing and familiarity with AMA Style Guide. Familiarity with scientific literature and proficiency with scientific literature databases (eg, MEDLINE, EMBASE, PubMed, etc.). Possess excellent written and verbal communication skills and ability to persuade with verbal and written communications involving multiple-disciplinary groups maintaining a high level of credibility and professionalism.Practices professionalism and integrity in all actions - demonstrating the ability to foster concepts of teamwork, cooperation, self-control, and flexibility.
What We Offer in Return
You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
Next Steps
If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
The next step is a virtual conversation with the hiring manager
The final step is a panel conversation with the extended team
Our people make a difference
At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.
Employer's Rights:
This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not an employment contract, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
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